CTRI/2020/10/028511招募中1 期
Can cerebral oximetry by near-infrared spectroscopy predict clinical and radiological deterioration in conservatively managed traumatic brain injury patients? A prospective observational study.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- JIPMER
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •We will include non-operatively managed, adult, TBI patients who present within 24 hours of trauma, and in whom the treating team anticipates a progression of CT findings or clinical deterioration in the next three days. This could be based on any combination of findings such as sizable contusions, acute subdural hematoma, and brain edema with partial or complete obliteration of cisterns. The decision will be made by the treating team. Since there are innumerable clinical situations, and due to the absence of level 1 (RCT) evidence for surgical decision making, we are not providing strict, exhaustive criteria, but we would like to leave it to the treating teamâ??s best judgment.
排除标准
- •Patients who require immediate operative intervention as per judgment of the treatment team which is expected to follow the guidelines of the Brain Trauma Foundation. (The guidelines of the BTF for surgical intervention are not level 1 but are expert opinions themselves)
- •Patients who are planned for barbiturate coma or similar burst suppression techniques.
- •Pure diffuse axonal injury without edema or significant hematoma or cisternal obliteration where deterioration is only expected because of progressive axonal damage.
- •Pure brainstem contusions or pure posterior fossa hematomas.
- •A patient with traumatic great vessel dissection causing an infarct that is visible in the initial scan.
- •Patients who have multiple system injuries besides TBI, who could go into hypotension or hypoxia that could affect the rSO2 levels or who are already in hypotension or hypoxia due to any cause.
- •Patients who have large skin abrasion or laceration or contusion over the forehead, that prevents the application of the sensor electrodes
- •A patient with an extradural hematoma or a thick subdural hematoma (1 cm or more) or thick pneumocephalus (5 mm or more, confluent) overlying the frontal brain at the forehead area since the signal might be absorbed by the blood or air.
- •A patient with grossly depressed fracture at the forehead area
- •Patients who are in a poor neurological status that survival for a period of one week is deemed unlikely
- •A patient with previous cranioplasty or surgical evacuation of a hematoma that caused a porencephalic change in the frontal lobes that could interfere with measurements.
研究者
相似试验
招募中
不适用
Efficacy of near-infrared spectroscopy cerebral oximetry on detecting ischemia during cross-clamping of the internal carotid artery - a prospective observational studyI63.5Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteriesDRKS00028613niversitätsklinikum Hamburg Eppendorf200
已完成
不适用
Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac SurgeryPostoperative ComplicationsNCT02155868Meshalkin Research Institute of Pathology of Circulation120
Unknown
不适用
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood TransfusionAnemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood TransfusionNCT01251068Zekai Tahir Burak Women's Health Research and Education Hospital40
Unknown
不适用
The Measurement Of Cerebral Oxygenisation With NIRS Method İn Polycythaemic Infants Might Add A Criterion To Indicate PPET?Cerebral OxygenationPeripheric OxygenationPolycythaemic InfantsNCT01255618Zekai Tahir Burak Women's Health Research and Education Hospital40
已完成
不适用
Normal Values of Brain OxygenationCerebral Arterial DiseaseNCT00512447University Hospital, Basel, Switzerland171